ES2281407T3 - INSTRUMENT FOR ANASTOMOSIS. - Google Patents

Abstract

A surgical instrument (10) to create an anastomosis, comprising: a housing (16a, 16b); a handle (14a, 14b) extending from the housing; a support member (26a, 26b) of clamping element extending distally from the housing, whose clamping element supporting member is configured and dimensioned to releasably support a plurality of surgical clamping elements (110) ; a firing mechanism (14a, 14b) of a clamping element that includes a driving member (24a, 24b) that is relatively movable in response to the actuation of the handle to simultaneously deform the plurality of surgical clamping elements; and characterized by; a tissue retention mechanism that includes a clip (40a1; 40a2) selectively movable from a first position with respect to the support member of fastener element to a second position in closer proximity to the support member of fastener element, of such that the tissue next to the support member of the fastener is held against it.

Description

Anastomosis instrument.

Background Technical field

This description refers to a surgical instrument to perform an anastomosis of structures of tubular body, and more particularly to an instrument to join vascular tissues, for example, during grafting procedures of coronary revascularization. Reference is made to U.S. patent applications with serial numbers 60 / 241,301, 09 / 410.817, 09 / 256.260, 08 / 877.701, which correspond to the following publications: document WO 02/32323, application EP 1 088519, U.S. Pat. No. 2002/0019647, application EP 0885595, respectively, and US Pat. 5,707,380 for information additional and requests related to the present invention.

Background of the technique related to invention

Coronary artery disease is often characterized by lesions or occlusions in the arteries coronary arteries that could result in inadequate blood flow to myocardium, or myocardial ischemia, which is typically responsible for complications such as angina pectoris, tissue necrosis cardiac (myocardial infarction), and sudden death. In some cases, Coronary artery disease could be treated by use of drugs and / or through changes in behavior and nutritional regimen. In other cases, dilation of the arteries coronary arteries could be achieved by procedures such as angioplasty, laser removal, atherectomy, catheterization, and vascular stents.

For certain patients, a graft of coronary revascularization (hereinafter CABG) is the preferred form  of treatment to relieve symptoms and often increase Life expectancy. A CABG procedure consists of a direct anastomosis of a vessel segment at one or more of the coronary arteries For example, an inverted vein segment saphene could be grafted at one end to the ascending aorta as a source of arterial blood and at the other end to an artery coronary artery at a point beyond arterial occlusion. Alternatively, the internal mammary artery (hereinafter IMA) located in the thoracic cavity adjacent to the sternum is analogously suitable for grafting a coronary artery, such as the left anterior descending artery (hereinafter THE D).

Performing a CBAG procedure typically requires access to the heart, blood vessels and tissue  associated. Access to a patient's chest cavity could be achieve in an open procedure by performing a large longitudinal incision in the heart. This procedure, to which referred to as a middle sternotomy, requires a saw or another cutting instrument to cut the sternum and leave two opposite halves of the rib cage that are deployed apart.

U.S. Pat. No. 5,025,779 issued to Bugge describes a separator that has been designed to grab the opposite halves of the sternum and extend the thoracic cavity apart. The large opening that is created by this technique allows the surgeon to directly visualize the surgical area and perform surgical interventions on the affected organs. However, such surgical interventions that involve large incisions and a substantial displacement of the grill Costal are often traumatic for the patient at risk significant concomitants. The recovery period could be Long and often it is painful. In addition, patients for which is indicated coronary surgery may need to give up said surgery due to the risks involved with obtaining access to the heart

U.S. Pat. No. 5,503,617 issued to Jako describes a separator configured to hold the surgeon for use in vascular or cardiac surgery in order to separate and keep ribs apart to allow access to the heart or to a lung through an "operating window": The separator includes a rigid frame and a translation frame Slidably attached to the rigid frame. Bottom pallets and above are rotatably mounted to the rigid frame and to the translation frame respectively. The solution of "window" enables the surgeon to gain access through a smaller incision with less rib displacement, and therefore, with less trauma for the patient.

Once access to the cavity has been obtained thoracic, surgery on the heart can be performed. Such surgical interventions typically require them to stop heartbeat while maintaining circulation at throughout the rest of the body. A cardioplegic fluid, such as potassium chloride (KCl) is discharged into the blood vessels of the heart to paralyze the myocardium. As described in the WO 95/15715 issued to Sterman et al., by For example, cardioplegic fluid is introduced into the myocardium to through the coronary arteries through a catheter inserted into the ascending aorta.

\hbox{paredes interiores de los vasos en los que debe pasar el
catéter.}

Alternatively, cardioplegic fluid is introduced through the coronary veins in a retrograde manner through a catheter in the inner jugular vein that has been accessed through the patient's neck. Such interventions require the introduction of multiple catheters in the blood vessels adjacent to the heart, which is a complicated intervention that requires that the corresponding vessels be located and properly accessed. The progression of the guide wires must be carefully monitored to determine proper placement. In addition, the introduction of catheters forms puncture wounds in the blood vessels that must be subsequently closed, and there is an increased risk of trauma to the

 \ hbox {inner walls of the vessels where the
catheter.} 

Alternatively, the CBAG intervention while allowing the heart to beat. To this class  of intervention is commonly referred to as miniincisive direct coronary revascularization (hereinafter MIDCAB). A surgical instrument is used to stabilize the heart and restrict blood circulation through the coronary artery during the graft procedure. Must be pay special attention to the interventions carried out in a heart beating, for example, synchronization interventions that they occur at certain stages in the cardiac cycle, such as between beats

To perform a CAGB intervention, the segment Captured vessel, such as IMA, is grafted to the artery coronary artery by a terminolateral anastomosis. Typically, it They use sutures to graft the vessel segments. However, the Conventional suture is complicated by the use of interventions mini-incisors, such as the window solution, for example, a limited access and reduced visibility to the surgical area could impede the surgeon's ability to apply manually Graft sutures. Additionally, it is difficult and time consuming Suture by hand if the CABG intervention is being performed while the heart is beating because suturing must be synchronized With the heartbeat

As can be seen, the process of suturing hand the captured segment of vessel to a coronary artery consumes time and requires a lot of skill from the surgeon. The resulting sutured anastomosis will also depend on the skill of the surgeon In mini-incisive interventions such as MIDCAB, the Suture capacity is even more complicated due to the limitation of maneuverability and visibility reduction. The patent of USA No. 5,707,380 issued to Hinchiffle et al., To which refers to the reader for further reference, describes an apparatus and a procedure that enables distant anastomosis without vessel perforation during conventional interventions and during mini-incisive interventions. However, there is a continuous need for surgical instruments and methods perfected to perform distance anastomosis both during conventional interventions as during interventions mimiincisivas.

EP 0 885 595 A1 describes a surgical instrument to perform anastomosis. The preamble of claim 1 is based on the instrument described in this document, which does not teach how to improve reliable tissue retention to the instrument before joining the two vessels.

Summary

This description refers to a surgical instrument to create an anastomosis that includes a housing that has a handle that extends from it and a support member of clamping element that extends in the distal direction from the accommodation. The support member of clamping element is configured and sized to support releasably a plurality of fasteners Surgical The surgical instrument also includes a mechanism tissue retention that has a clip that is movable selectively from a first position with respect to the member of clamping element support to a second position in a closest proximity to the element support member of fastening, such that the tissue located next to the member of holding element holder is held against it. A clamping element trigger mechanism is also included with the surgical instrument and includes a driving member that is moveable relatively in response to the actuation of the handle to simultaneously deform the plurality of elements of surgical support.

Preferably, the housing includes a pair of opposite housing parts each of which has a distal end that is movable in the directions of approach and move away from each other to define an approach distance between them. An approach control mechanism could be associate operatively with the first and second opposite parts of accommodation. The approach control preferably includes a vertical mounting member that joins the first and second parts of accommodation and an approach adjustment member that hooks to the vertical mounting member. It is contemplated that one of the parties first and second d housing is movable with respect to the other opposite housing part in response to the movement of the adjustment member with respect to the vertical mounting member. Be could also include an interlocking member that engages the vertical mounting member and enclave approach distance relative between the first and second opposite housing parts at a desired approach distance before shooting.

In one embodiment, the retention mechanism of fabric includes a drive bushing to move the Staple from the first position to the second position. Preferably, the tissue retention mechanism has including an interlocking member to retain the bushing of drive and to the clip in the second position.

In another embodiment, a piston is coupled to the driving member after actuation of the handle of such so that, after the release of the handle, both the member of fastener as the driving member are removed in proximal direction Preferably, the interlocking member retains the drive sleeve and the clip in the second position and also retains friction to the bushing of drive and to the clip above the support member of fastener in such a way that the bushing  and the staple are removed proximally with the member of support of clamping element after the release of the handle.

Still in another embodiment of the present description, a drive element is coupled to the grip and controls both the trigger element mechanism of clamping as the approximation of the opposite parts of accommodation.

\hbox{conjunto ordenado
sobre el miembro de soporte de elemento de sujeción.}

In yet another embodiment, the surgical instrument includes a housing having a support member of a fastener attached thereto which is configured and sized to releasably retain a plurality of surgical fasteners. A drive assembly is actively associated with the support member of the fastener to facilitate deformation of at least a portion of the surgical fasteners, and a tissue retention mechanism is selectively operable to retain the tissue adjacent to the elements. of surgical clamping before deformation. Preferably, the surgical fasteners are arranged in a manner similar to a

 \ hbox {ordered set
on the support member of the clamping element.} 

In one embodiment, the retention mechanism of fabric includes a drive sleeve and at least one clip of tissue that is movable from a first position, in which the bushing and the fabric clips occupy relative positions with respect to the fasteners surgical, to a second position in which the bushing of drive and tissue clips are in close proximity narrows to surgical fasteners. The set of drive is fixed at one end to a handle and fixed at one end opposite a drive member that is mounted to the clamping element support member such that the drive assembly movement will make a move  reciprocating of the driving member, which, in turn, will make a reciprocating movement to the support member of clamping element to deform at least a part of the fasteners Surgical Preferably, the element support member of clamp includes a firing piston that engages and engages with the drive member after activation of the drive assembly and to a hammer part. The hammer part has been sized preferably to lean very close to each of the elements of surgical support in order to deform at least a part of the surgical fasteners after the movement of the drive assembly.

A capture device could be incorporated hammer with the firing piston, such that, after the activation of the drive assembly, the driving hammer hook the hammer capture device and lock the member impeller to the firing piston and, after the release of the set of drive, both the driving member and the firing piston withdraw in the proximal direction.

This exhibition also describes a method of performing a vascular anastomosis that is useful for understand the invention, and includes the steps of:

a) provide a surgical instrument that It includes:

a top and a bottom, each of the parts having an element support member of clamp mounted on them that is configured and sized to retain a plurality of fasteners surgical;

a drive assembly that is coupled to a of the parties and cooperates with the element support members of clamping to deform at least a part of the elements of surgical restraint;

b) return out a first end of a first vessel on a distal end of one of the support members of fasteners in such a way that the first end of the first glass hook to the fasteners surgical retained therein;

c) return out a second end of a first vessel on a distal end of the other of the members of support of clamping element such that the second end of the first glass hook to the surgical fasteners retained therein;

d) insert the distal end of both clamping element support members in an opening practiced on a side wall of a second vessel;

e) couple the side wall of the second vessel with the surgical fasteners adjacent to the opening;

f) activate the drive assembly to cooperate with the clamping element support member with in order to deform the surgical fasteners to fix the first and second vessels together in communication for passage of fluid with each other.

Preferably, the method further includes the step of approximating the distance between the two opposite parts with relation to the size of the opening of the first vessel before the insertion of the first vessel into an opening made in a wall Side of a second glass.

In one method, after the second stage of back out, the method also includes the stage of placing the support member of fastener element of the upper parts e bottom in a longitudinally offset manner so that it create an angle with respect to the transverse plane of the two parts before inserting the first vessel into an opening in a wall Side of a second glass.

Brief description of the drawings

Other objects and features of the present invention will be apparent from the following description Detailed considered in relation to the attached drawings. Without However, it will be understood that the drawings have been designed only to illustrative title and not as a definition of the limits of invention.

Hereafter described herein memory an illustrative embodiment of the instrument and method surgical object of the invention with reference to the drawings, in the that:

Figure 1 is a perspective view of a surgical instrument constructed in accordance with one embodiment preferred of the present description;

Figure 2 is a partial perspective view, on an enlarged scale, of the indicated area of detail of Figure 1 which shows the upper and lower element support members of surgical support in a withdrawn configuration, pre-loaded;

Figure 3 is a cross-sectional view. of the upper support member of the surgical clamping element taken along line 3-3 of the Figure 2;

Figure 4 is a perspective view with separate parts of the surgical instrument of Figure 1;

Figure 5 is a perspective view with separate parts of the bottom of the instrument surgical;

Figure 6 is a perspective view with separate parts of a support member of fastener surgical;

Figure 7 is a partial perspective view and on an enlarged scale, of a support tongue for the member of Surgical support element support;

Figure 8 is a cross-sectional view. horizontal of the surgical instrument of Figure 1;

Figure 9 is a cross-sectional view. horizontal, at an enlarged scale, of the indicated area of detail shown in Figure 8;

Figure 10 is a plan view of a surgical separator set placed on a patient's chest  to get access to the heart;

Figure 11 is a partial view in perspective, on an enlarged scale, of the element support member of surgical support shown with a part of the IMA turned out on a plurality of fasteners Surgical with tissue fixation spikes shown on a retired position;

Figure 12 is a cross-sectional view. horizontal of the surgical support element support member  of Figure 11 shown with a drive sleeve and a fabric clamp in a retired position.

Figure 13 is a cross-sectional view. horizontal of the support member d surgical clamping element which shows the drive sleeve by pressing a tab interlocking and forcing the tissue clamp to move forward on the fabric turned out;

Figure 14 is a cross-sectional view. horizontal of the surgical support element support member  of Figure 11 showing the drive sleeve interlocked in position and to the tissue spikes fixed above the fabric turned out;

Figure 15 is a partial view in perspective, on an enlarged scale, of the element support member clamping with a part of the IMA turned out over the surgical fasteners with the tissue spikes shown in a hooked and fixed position on top of the fabric turned towards outside;

Figure 16 is a cross-sectional view. horizontal of the surgical instrument shown with the parts upper and lower being loaded with spring towards each other to facilitate the loading of the "heel" part of the IMA;

Figure 17 is a cross-sectional view. horizontal of the surgical instrument showing the upper dial of interlocking being selectively positioned at a distance fixed between the upper and lower parts, which allows the user approximate the size of the distal opening of the IMA;

Figure 18 is a partial perspective view of the upper and lower element support members of surgical fixings shown with the "tip" parts and "heel" of the IMA fixed on top of each set of elements surgical clamping, respectively;

Figure 19 is a view of an incision practiced in the LAD;

Figure 20 is a cross-sectional view. horizontal of the distal end of the element support member of clamp showing the non-approximate fixed tissue of the IMA being inserted into the incision of Figure 19;

Figure 21 is an enlarged view of the area of detail indicated in Figure 20;

Figure 22 is a view similar to Figure 21, which shows the IMA being widened within the incision of the LAD when the handles are released and also showing the dial of lower interlocking located against the upper part for interlock the upper and lower parts;

Figure 23 is an enlarged view of the indicated area of detail of Figure 22 at the point of insertion;

Figure 24 is a partial perspective view of a driving member before coupling with an anvil of the firing piston;

Figure 25 is a cross-sectional view, on an enlarged scale, taken along the cutting line 25-25 of Figure 24;

Figure 26 is a view similar to Figure 21 during instrument firing and showing the bars of drive by moving the longitudinal reciprocating movement to driving member;

Figure 27 is a cross-sectional view, on an enlarged scale, of the indicated area of detail of Figure 26 in the coupling point of the drive member and the anvil higher;

Figure 28 is a partial perspective view of the driving member forcing the anvil in the distal direction towards surgical fasteners;

Figure 29 is a cross-sectional view, on an enlarged scale, taken along the cutting line 29-29 of Figure 28;

Figure 30 is a cross-sectional view. horizontal of the distal end of the instrument showing the driving members loading the fasteners with spring surgical towards the anvils of the upper and lower parts and deforming the surgical fasteners to fix the IMA to the LAD;

Figure 31 is a cross-sectional view, on an enlarged scale, of the indicated area of detail of Figure 30;

Figure 32 is a partial perspective view of the surgical instrument after firing, which shows the withdrawal in cooperation relationship of the support member of fastener and drive member;

Figure 33 is a cross-sectional view. horizontal taken along the cutting line 33-33 of Figure 32;

Figure 34 is a view showing the "heel" and the "tip" of the IMA attached to the LAD; Y

Figure 35 is a view showing the Anastomosis terminated.

Detailed description of preferred embodiments

Embodiments are described below. Preferred surgical instrument and method exposed in the present report in relation to a surgical intervention called "miniincisive direct coronary revascularization" (hereinafter MIDCAB) in which a vascular anastomosis is created by joining a section of a captured vessel, for example the internal mammary artery (hereinafter "IMA") or a vein saphenous, to derive an occlusion in a coronary artery, by example the left anterior descending artery (hereinafter "THE D". Alternatively, the surgical instrument currently described could be used in performing anastomosis of other tubular contact body structures.

In the drawings and in the description that follows, the term "proximal", as is traditional, refers to the extreme of the device that is closer to the user, while the term "distal" refers to the end that is furthest from the Username.

Referring now in detail to the figures of the drawings, in which the reference numbers identify similar or identical elements, an embodiment of the present disclosure has been generally illustrated in Figure 1 and designated therein as an instrument Surgical 10. The surgical instrument 10 includes a pair of opposite upper and lower parts 12a and 12b, respectively, which include generally symmetrical handle parts 14a and 14b and housings 16a and 16b, respectively. Preferably, the handles 14a and 14b are provided with ergonomic surfaces 9a and 9b, respectively, which are contoured and configured so that they can be comfortably grasped with the user's hands during operation of the
instrument.

As the upper and lower parts 12a, 12b of the surgical instrument 10 are generally symmetrical, the part opposite upper 12a and the elements described with respect to the the same shall be designated hereinafter, with the suffix "a" and the corresponding elements of the part lower 12b will be designated with the suffix "b".

As shown in Figures 1 to 5, the upper part 12a and lower part 12b are fixed in their proximal ends by bolt 50 which allows the movement of pivoting of the upper part 12a with respect to the part bottom 12b around bolt 50 (see Figure 4). Preferably, and as will be best seen in Figure 4, the end proximal 13a of housing 16a and proximal end 13b of housing 16b are coupled together with each other around the bolt 50.

The upper part 15b of the proximal end is of semicircular shape and the upper part of the proximal end 13a is correspondingly sized as an annular flange 25a that receives conjugate to part 15b of the proximal end 13b. Similarly, the bottom 25b (see Figure 8) of the end 13b It is also ring-shaped in order to receive conjugate to part 15a when instrument 10 is assembled.

The housing 16a also includes a slot or longitudinal channel 17a of handle practiced therein extends from the proximal end 13a of the housing 16a towards the distal end of it. Preferably, the handle 14a is it houses inside the groove 17a and is pivotally fastened inside of housing 16a by bolt 52a. Similarly, the bolt 52b pivotally holds the handle 14b inside the groove 17b of accommodation 16b. As best illustrated in Figure 4, the bolts 52a and 52b play an additional function, that is, the outer ends of each pivot bolt 52a, 52b protrude out of the side of each housing 16a, 16b, of such that the pivot bolts 52a, 52b also act as hubs for torsion springs 18 when the top 12a and the lower part 12b are conjugately coupled. Plus particularly, a pair of loop ends 19a, 19b formed in the torsion springs 18 are sized enough to surround bolts 52a, 52b, respectively.

As depicted in Figure 5, the housing 16b further includes a second slot or channel 21b that It has been sized to slidably accommodate a bar articulated drive 20b therein. The articulated bar 20b drive is pivotally fixed at its end proximal to the handle 14b by the pin 70b that locks the bar 20b in position inside the handle 14b. More particularly, the bar articulated drive 20b has a hole 102b that aligns with the hole 71b of the handle 14b when the bar 20b is fixed to the handle 14b. Pin 70b is inserted through the holes 71b and 102b to fix the articulated bar 20b to the handle 14b.

The distal end of the articulated bar 20b of drive slides inside slot 21b and it is slidably fixed to housing 16b by bolt 64b sliding through a pair of parallel side channels 99b and 100b (see also Figure 8) each of which is located in relation of separation within the groove 21b. Bolt 64b of also fixed a drive member 24b to the distal end of the articulated drive bar 20b, which is explained by more detail later.

Housing 16b also includes a second torsion spring 68b that is fixed at one end to the housing 16b through a hole 74b and loaded with spring at the end opposite against a proximal part of the handle 14b, by example, block 72b loaded with spring. The spring 68b stimulates the movement of housing 16b and handle 14b in one way opposite one with respect to the other, while the articulated bar  Drive 20b which is fixed between the housing 16b and the handle 14b limits the total distance of the opposition movement between the two members 14b and 16b.

As mentioned above, the member impeller 24b is also attached to the distal end of the bar 20b articulated by the sliding pin 64b. Preferably, the proximal end of the drive member 24b is bifurca to form spikes 77b and 79b that, together, define a slot 78b between them. Each barb 77b and 79b includes a part stepped 85b and 84b, respectively, which cooperate to limit the movement in the proximal direction of the drive member 24b, what which is described in greater detail below. The driving member 24b also includes a pair of opposite holes 66b and 67b located distally of the staggered parts 84b, 85b and sized enough to accommodate the sliding bolt 64b. How I know shown in Figure 5, the inner face of the drive member 24b is preferably concave and is sized to be submerged under conjugate form and attach to the outer surface of the accommodation member 16b in a manner like a slide.

During assembly of the surgical instrument 10, the drive member 24b slidably engages the outer surface of the housing 16b such that the slots 78b and 21b are in a general vertical alignment each. Preferably, the stepped portions 84b, 85b are placed on the distal side of a stop 62b that is fixed to one side of the housing 16b so as to limit the proximal movement of the  driving member 24b with respect to housing 16b and, in turn, limit the distance between the handle 14b and the housing 16b. The jointed bar 20b is located inside the groove 78b and side channel 100b. Sliding pin 64b is inserted through hole 66b, through side channel 99b of housing, through the hole 104b of the articulated bar 20b of actuation, through the side channel 100b and through the hole 67b for locking the articulated drive bar 20b to the driving member 24b and slidably locking the member impeller 24b within the side channels 99b and 100b of the accommodation 16b.

As can be seen, the movement Longitudinal length of the articulated bar 20b is limited by the proximal and distal ends of the channels laterals 99b and 100b and, in turn, the longitudinal movement of the drive member 24b is controlled by the articulated bar 20b of drive As mentioned earlier, the movement in the proximal direction of the drive member 24b is limited also due to the stepped part 85b that rests on the stop 62b

Figures 4 and 5 also show the position relative of a pair of interlocking dials 22a and 22b with respect to to the upper and lower parts 12a and 12b. Preferably a first end of a vertical mounting member 56 is designed to adjust through a pair of vertically aligned holes 80b and 82b practiced in the drive member 24b and in the accommodation 16b, respectively. The second end of the member of vertical mount 56 is designed to fit through another pair of vertically aligned holes 80a and 82a located in the drive member 24 and housing 16a, respectively (see Figure 8).

As best illustrated in Figure 4, the interlocking dial 22b is screwably coupled to the member of vertical assembly 56 and is disposed between the upper parts e lower 12a and 12b. The interlock dial 22a, which is also attaches in a threadable manner to the vertical mounting member 56, it is disposed between the upper part 12a and the handle 14a. Of this mode, the orientation of interlocking dials 22a and 22b allows a user to approximate the widened size of the IMA 120 before inserting the IMA into the LAD (see Figure 18) and locking the parts 12a and 12b with each other to start firing the instrument 10, as explained in greater detail below with respect to Figures 16 and 17.

As best seen in Figures 5 and 8, the accommodation members 16a and 16b also include parts of car 27a, 27b, located at their respective distal ends. Plus particularly, Figure 5 shows the carriage part 27b located distally of the hole 82b on the housing member 16b. Preferably, the inner surface of the carriage 27b is concave and has been sized enough to receive the member of support 26b of fastener whose outer surface is generally convex. Bolts 36b and 39b fix the distal end of the support member 26b of fastener within the carriage 27b More particularly, bolt 36b has been inserted through slot 58b1 of drive member 24b and then through the holes 60b1 arranged on one side of carriage 27b and also at through the groove 35b extending through the sides of the support member 24b of fastener. The pin 36b is then extends through the hole 58b2 to engage so slidable to the distal end of the element support member 26b clamping inside the car 27b.

In much the same way, bolt 39b fixes the proximal end of the support member 26b of fastening to carriage 27b through slot 58b1 and holes 61b1, 37b, 61b2, respectively, and finally through slot 58b2 to slidably engage the proximal end of the member of support 26b of fastening element to carriage 27b. How it looks better in Figure 5, bolts 36b, 39b have been inserted through channels 58b1 and 58b2 located on opposite sides of the member impeller 24b and slidably fix the impeller member 24b to the housing 16b, which also facilitates sliding movement of the drive member 24b with respect to the housing 16b.

Returning now in detail to Figures 2 and 6, which show a preferred embodiment of the support members 26a and 26b of fastener, the support member 26a of clamping element includes a firing piston 34a which has a hammer part 46a located at the distal end thereof, a semi-annular flange 86a located at the end proximal thereof and an anvil 49a located between them. He proximal end of the semi-annular flange 86a has a pair of surfaces with cam action 88a1 and 88a2 and the end distal of the semi-annular flange 86a has a stepped semi-annular surface 92a.

Preferably, the hammer part 46a of the firing piston 34a has a generally arcuate shape and includes three spikes 59a1, 59a2 and 59a3 and, therefore, have formed a pair of slots 67a1 and 67a2 between the three spikes 59a1, 59a2 and 59a2 of hammer, respectively.

A tissue fixing clip 43a is slidably coupled to the distal part of the firing piston 34a and is disposed between a distal end 73a of the anvil 49a and the hammer 46a. Advantageously, the inner periphery of the clip of 43a fixing is concave, to facilitate sliding movement above the firing piston 24a. Preferably, the staple of fixing 43a also includes hanging side tabs 89a longitudinally, which are sufficiently sized to slide the outer periphery of the part slidably hammer 46a of firing piston 34a. The fixing clip 43a it also includes an interlock tab 44a and a pair of 40a1 and 40a2 fabric clamps, flexible and finger-like, that move with cam movement up and in direction distal from the rest of the fixing clip 43a.

As best shown in Figures 3 and 6, a U-shaped drive sleeve 42a is sized enough to slidably engage the periphery exterior of fixing clip 43a. More particularly, the drive bush 42a is preferably concave, and each one of the longitudinal side edges thereof includes a 63a1 and 63a2 side tab that extends inward that is sized to slidably fit to the outer periphery of the fixing clip 43a and retaining the fixing clip 43a above the firing piston 34a (see Figure 3). When he drive bushing 42a slides over the distal parts of the fabric clamps 40a1, 40a2, the fabric clamps 40a1, 40a2 exert a downward cam action between the grooves 67a1 and 67a2 of the hammer part 46a, whose object is explained by greater detail later with respect to the operation of the surgical instrument 10.

The support member 26a of element of clamp also includes an anchor bushing 48a that is fixed by means of bolts 36a, 39a to the accommodation member 16a to through holes 35a and 37a in the manner described above and as best seen in Figure 6. Preferably, the distal end of bushing 48a is semicircular and includes a support section 113a of surgical fastener which has an ordered semiannular set of channels or cots 111a Longitudinal support of surgical fixation element each one of which is configured and sized to support in the same a surgical fastener generally in shape of "C" or staple 110 by, for example, friction or partial compression of the staples 110. Preferably, the cradles 111a oriented longitudinally form an ordered set eccentric radially around the outer surface of the anchor bushing 48a. This arrangement serves to form a angled joint or fistula between the vessels to be joined. It has been observed that this type of union could facilitate better circulation of fluid through the anastomotic zone.

As shown in more detail regarding Figures 8, 9 and 11, a single fastener 110 is located inside each cradle 111a so that it is supported very fence against an anvil 112a that is radially arranged in the most distal end of anchor bushing 48a. Once assembled, the hammer part 46a of the firing piston 34a is supported tightly against the opposite end of each fastener  110 to partially compress each clamping element 110 and, in consequently, retaining each fastener 110 within the respective cradle 111a.

When assembled, bushing 42a of U-shaped drive is coupled above the piston of shot 34a with the fixing clip 43a held by friction in position between them. The bushing 42a is located above the fixing clip 43a in a removed position, such that the inner distal edge 65a of the sleeve 42a of drive rests closely on tab 44a of extended upward interlocking of fixing clip 43a and the proximal edge 81a of the drive sleeve 42a is supported on the inner front edge 73a of the anvil 49a, as it looks best in Figure 11. Once assembled, clamps 40a1 and 40a2 of tissue are preferably placed in a vertical alignment general with slots 67a1, 67a2, respectively, in such a way which, when the fabric clamps 40a1, 40a2 exert an action cam down by the 42a bushing movement of drive on fixing clip 43a, pins 40a1 and 40a 2 of tissue descend through slots 67a1 and 67a2 and embrace end 124 of the fabric turned outward 120 (see Figure 15). This is explained in greater detail below with respect to operation of the support member 26a of subjection.

Referring back to the Figure temporarily 6, a rod 32a and an annular sleeve 41a have been inserted to through a groove 75a of the firing piston 34a and are kept in position by means of an anchor ring 33a located near the distal end of bushing 48a. The stem 32a, in combination with the ring bushing 41a, work to slide the coupling slidably distal end of the firing piston 34a to the distal end of the anchor bushing 48a. The firing piston 34a is coupled also slidably to anchor bushing 48a by means of a rod 30a that has been inserted through a slot 79a of the firing piston 34a and housed inside a ring 31a of the anchor bushing 48a. Preferably, the stem 30a is coupled by friction to ring 31a. However, in some cases it could be it is preferable to retain the rod 30a within the ring 31a of some otherwise, for example, with glue or by snap adjustment.

Once the member of has been assembled fixing element support 26a, fixing elements Surgical 110s are held in position within cribs 111 against the annular flange 112a by the pins 59a1, 59a2 and 59a3 Hammer More particularly, and as best seen in the Figures 6 and 7, a tongue-shaped strap 94a has been inserted through of a groove 98a located within the anchor bushing 48a and it is loaded with spring against a more internal proximal edge 97a of the slot 98a in order to force the rear end 96a of the firing piston 34a towards the firing position, that is, the 59a1-59a3 hammer spikes are forced distally to rest on the proximal end of the fasteners surgical 110 and to partially compress each element of clamping 110, thereby retaining each clamping element 110 within their respective cradle 111a.

In use, and as shown in Figures 8 to 35, the surgical instrument 10 facilitates the realization of a vascular anastomosis and eliminates and / or minimizes the need for manual suture of the vessels. The method and use described in This report shall apply as regards an anastomosis. vascular miniincisiva performed in a beating heart as in a MIDCAB surgical intervention. However, the instrument Surgical 10 described herein could also be used in the performing anastomosis of other body structures Tubular or contact without departing from the scope of this description. For example, surgical instrument 10 could be use in conventional open graft interventions coronary revascularization (CABG) using a medium sternotomy or another large incision without stopping the heart. Alternatively, it could use the thoracic "window" intervention to get access to the heart The concept of "window" implies a smaller incision and less rib displacement, and by so much is less traumatic for the patient. For this concept, it they use conventional surgical techniques to determine the place of the incision to access the thoracic cavity.

To get access to the heart, after make an incision, a separator set could be used surgical to separate the ribs in the area of the incision as shown in Figure 10. Specifically, a base 129 in the patient's chest placing the central opening defined by the base over the area of the operation. They are fixed spacer assemblies 130 to base 129 at various points. Every spacer assembly 130 includes a vane that has a hook for hook a rib or sternum with it. The sets separators are fixed and used to separate ribs until they are define a sufficiently large opening in the thoracic cavity to provide direct access to the heart. For example, him sternum and fourth and fifth ribs can be separated to Create a window They could also be used for an intervention  particular other configurations of dispersing the ribs and / or selectively cut individual ribs separating them from the breastbone.

Once the desired access to the heart has been obtained, the graft vessel, for example the internal mammary artery (IMA) is dissected from the surrounding cartilage and muscle, and a free end of the vessel is exposed. The occluded coronary artery, for example, the left anterior descending artery (LAD) 128, is then prepared to receive the graft of the IMA 120. The heart is placed in the desired orientation, either by traction sutures that pass through the pericardium. , or by manipulation with heart manipulative instruments held by the surgical staff or fixed in a fixed orientation to a base such as the base of the separator assembly. Blood circulation through LAD 128 can be restricted by cardiopulmonary bypass and pericardial cooling. Alternatively, a damping instrument could be applied directly on LAD 128 to restrict blood circulation and reduce the movement of the heart near the
THE D.

Returning now in detail to the operation of surgical instrument 10 and in particular to the member of support 26a of fastener as detailed in the Figures 11 to 15, once the IMA 120 has been captured, the user turn out the top (the "tip") of the end free 124 of IMA 120 on the distal end of the member of support 26a of clamping element such that the end Free of the IMA 120 is retained by the most distal parts of the surgical fasteners 110. The outward turn of the IMA 120 could be achieved through any instruments suitable known and / or techniques such as using presses. With the IMA 120 turned out this way, the user then force to the bushing 42a in the distal direction grasping the side edges 116a of the drive sleeve 42a. Preferably, each of the side edges 116a of the drive bush is formed with a surface type of grip, for example, a rough surface, which facilitates a grip firm during the distal movement of the drive sleeve 42a during operating conditions.

As shown in Figures 13, 14 and 15 when the user initially moves forward the drive bushing 42a, both the drive bushing 42a and the fixing clip 43a move distally until the leading edge 45a (see Figure 11) of the fixing clip 43a rests on the sleeve 41a limiting the additional distal movement of the fixing clip 43a. The movement of the fixing clip 43a in the distal direction against the bushing 41a tightens the fabric clamps 40a1, 40a2 on the "tip" part of the fabric turned outward 124 above the holes 67a1, 67a2. The user continues to force the drive bushing 42a distally over the fixing clip 43a such that the flexible locking flange 44a is depressed by the drive bushing 42a and, simultaneously, the distal part of the drive bushing 42a exerts a cam action on the tissue pins 40a1, 40a2 down in the direction of the fabric turned outward 124 on the surgical fasteners 110 and in the holes 67a1, 67a2 as best seen in Figures 13 and
14.

The user continues to move the cap of drive 42a in the distal direction until the inner edge  65a of the drive sleeve 42a rests on the stem 32a and the tab jumps elastically back to its position neutral not loaded with spring interlocking the bushing drive 42a against the stem 32a and locking the spikes of tissue 40a1, 40a2 in a position embraced above tissue 124 end as shown in Figures 14 and 15.

The user then squeezes the handles upper and lower 14a and 14b, respectively, such that the handles 14a and 14b pivot around the bolts of pivoting 52a and 52b causing the two support members 26a and 26b of fixing element move towards each other. This allows the user to turn the opposite end out of the IMA 120 (the "heel") on the fasteners Surgical 110 as shown in Figure 18. The same procedure described above is used to fix the part of "heel" of the IMA 120 on the fasteners Surgical 110 using the support member 26b of clamping, as best seen in Figure 18.

In some cases it might be preferable to orient the upper and lower parts 12a and 12b in a slightly deflected in the longitudinal direction so that an angle is created with respect to the transverse plane of the two parts 12a, 12b with the in order to optimize the anastomosis and facilitate circulation Optimum blood through the graft area from the IMA 120 until LAD 128. This union will create a "heel" effect and "most dramatically visible" tip in which it is defined clearly an acute or obtuse angle between the vessels.

As can be seen from this description, the initial tightening of the handles 14a, 14b cause that the distal ends of the support members approach 26a and 26b of clamping element and does not result in the bars of drive 20a, 20b and drive members 24a, 24b are slide into slots 99a, 100a and 99b, 100b. This Particularly advantageous feature is because the springs of torque 18 have a force that is less than the force of spring of either of the two springs 68a or 68b of handle; and / or that the upper part 12a and the lower part 12b are not loaded with spring, that is to say, that they can move freely, a with respect to the other.

The remaining part of IMA 120 is located between the upper and lower parts 12a and 12b, respectively, of such that the remaining part of IMA 120 is arranged proximally with respect to instrument 10, facilitating that IMA 120 insertion mode in LAD 128 as described previously.

Figures 16 and 17 show the process in two stages to approximate the size of the IMA 120 distal opening before insertion into LAD 128, in order to prevent the IMA 120 becomes over-widened within LAD 128. The user re-tighten the handles 14a and 14b which, in turn, move pivotally to the support members 26a and 26b of element of subject to each other. The tissue spikes 40a1, 40a2 and 40b1, 40b2 retain the end portion 124 of the IMA 120 above the plurality of surgical fasteners 110. The user then gradually release the handles 14a, 14b until set the desired widened position of the IMA 120 distal opening as illustrated by the reference letter "B", and then turn dial 22a around the vertical mounting member 56 such that dial 22a rests on top 12a thereby restricting the vertical movement of the part superior 12a between dials 22a and 22b as seen best in the Figure 17. Once the handles 14a, 14b have been released, the user can adjust the size of the opening in increments "B", for example, to make it smaller or larger, turning the dial 22a in the proper sense to carry out said operations. This approximates the desired widened size of the distal opening of the IMA 120 before insertion into the LAD.

Returning now to Figures 19 to 23, these show IMA 120 being inserted through an incision 130 practiced in LAD 128. More particularly and as shown better in Figure 20, the user tightens the handles again 14a, 14b one relative to the other that move the members of support 26a, 26b with respect to each other, as illustrated by the letter "A" for reference. The user then inserts the distal ends of the support members 26a, 26b of fastening in the incision 130 such that the distal end of each of the plurality of fasteners 110 and the parts end 124 turns out of the fabric 124 of the IMA will have sufficiently inserted inside and through the incision 130. As it looks best in the enlarged view of the Figure 21, the proximal ends of the fasteners Surgical 110 remain outside the incision 130.

The user then releases the handles 14a, 14b such that the opening of the IMA 120 expands to its approximate default distance "B" within the incision 130, as best seen in Figures 22 and 23. Once the IMA 120 has been properly expanded within LAD 128, the user then turn dial 22b around its mounting member vertical 56 towards the top 12a such that the dial 22 b is supported and loaded with spring to part 12a against part 12b. The instrument is now preconfigured to shoot.

Figures 24 to 33 show the sequence of shot of instrument 10, that is, when you press the handles 14a, 14b the user .. More particularly, the Figures 24, 25, 27, 28, 29, 31, 32 and 33 show the member's shot upper support 26a of fastener. It will be understood that the lower support member 26b of fastener and the respective component parts fire simultaneously with the upper support member 26a of fastener.

Figures 24 and 25 show the distal part of the impeller member 24a before coupling with the piston of shot 34a. From that moment, the user presses both handles 14a, 14b and, as parts 12a and 12b are now interlocked with respect to each other, the movement of handles now cause the articulated bars 20a and 20b of drive slide in distal direction within the channels sides 100a, 99a and 100b, 99b as shown in Figure 26. Simultaneously, and as shown with respect to the top 12a, hammers 28a1 and 28a2 are forced on the surfaces of cam 88a 1 and 88a2 (see Figure 28) of the semiannular flanges 86a, 86b. Sliding bolts 36a and 39a ensure movement coherent longitudinal of the driving member 24a within the slots 58a1 and 58a2.

As the user continues to press together the handles 14a, 14b, the driving hammers 28a1 and 28a2 continue moving in the distal direction to leave free to cam surfaces 88a1 and 88a2 and mate with their respective hammer 38a1 and 38a2 capture devices, as see better in Figure 32. Once coupled, the distal edge front 106a of the drive member 24a rests on the rear stop 90a that works to limit the additional movement in the distal direction of the drive member 24a with respect to the firing pistons 34a.

As the user continues to squeeze the handles 14a, 14b together, the articulated drive rods 20a, 20b communicate a longitudinal movement to the driving members 24a, 24b against the firing pistons 34a, 34b (see Figures 26 to 29), which, in turn, drives the hammers 59a1, 59a2, 59a3 (and 59b1, 59b2 and 59b3 (not shown in this figure)), in the distal direction to deform the fasteners 110 and firmly hold the IMA 120 to LAD 128 in fluid flow communication as shown in the Figures
30 and 31.

With reference to Figures 32 and 33, after release of handles 14a, 14b, torsion springs 68a, 68b load the handles out, returning from that mode to the driving members 24a, 24b to their position prior to Shooting. As the driving members 24a, 24b and the pistons of shot 34a, 34b are now coupled to each other, the pistons of shot 34a, 34b along with support members 26a, 26b of clamping element are also removed proximally in response to the release of the handles 14a, 14b due to the friction coupling between drive bushings 42a, 42b and fixing clip 43a, 43b as shown in Figure 33.

Figure 34 presents the result of the shot of surgical instrument 10, that is, the "heel" and the "tip" of the IMA 120 have been set to LAD 128 by means of a plurality of surgical fasteners 110. How can appreciate, once the "heel" and the "tip" of the IMA 120 are subject, the user can complete the anastomosis by fixing additional surgical elements of fastening 132 to the side parts between the two vessels 120, 128 as depicted in Figure 35.

It will be understood that they could become diverse modifications to the embodiment shown herein. For example, instruments could be sized to perform an anastomosis for other vessels and contact tissue. So, The above description should not be considered in character limiting, but merely as examples of embodiments preferred. Those skilled in the art will contemplate other modifications within the scope of the appended claims as an appendix to this report.

Claims (16)

1. A surgical instrument (10) to create an anastomosis, which includes: a housing (16a, 16b); a handle (14a, 14b) extending from accommodation; a support member (26a, 26b) of element of clamp that extends distally from the housing, whose clamping element support member is configured and sized to releasably support a plurality of surgical fasteners (110); a firing mechanism (14a, 14b) of a clamping element that includes a driving member (24a, 24b) that is relatively movable in response to the actuation of the handle to simultaneously deform the plurality of surgical clamping elements; and characterized by; a tissue retention mechanism that includes a clip (40a1; 40a2) selectively movable from a first position with respect to the element support member clamping to a second position in closer proximity with the clamping element support member, such that the tissue located next to the element support member of hold is held against it. 2. A surgical instrument to create a anastomosis according to claim 1, wherein the housing includes a pair of opposite parts (16a, 16b) of accommodation each of which has a distal end, whose distal ends are movable approaching and separating between yes to define an approach distance between them. 3. A surgical instrument to create a anastomosis according to claims 1 or 2, comprising  in addition an associated approach control mechanism operationally with the first and second opposite parts of housing and that includes a vertical mounting member (56) that joins the first and second housing parts and a member (22nd, 22b) approach adjustment that attaches to the mounting member vertical, in which one of the first and second opposite parts of accommodation is movable with respect to the other party accommodation opposites in response to the movement of the member of adjustment with respect to the vertical mounting member to configure selectively a maximum approach distance. 4. A surgical instrument to create a anastomosis according to claim 3, wherein the approach control mechanism further comprises a member of interlocking approach control (22a, 22b) that engages to the vertical mounting member and interlock the relative approach between the first and second opposite housing parts. 5. A surgical instrument to create a anastomosis according to claim 2 or one of the claims 3 and 4, as soon as they are subordinated to the claim 1, wherein the tissue retention mechanism it also comprises a drive bushing (42a) to move the Staple from the first position to the second position. 6. A surgical instrument to create a anastomosis according to claim 5, wherein the tissue retention mechanism further comprises a member of interlock (44a) to retain the drive sleeve and a the clip in the second position. 7. A surgical instrument to create a anastomosis according to any of the claims precedents, in which the clamping element support member further comprises a piston (34a, 34b) that engages the member impeller after actuation of the handle, such that, Upon release of the handle, both the member member clamping as the driving member are removed in the direction proximal 8. A surgical instrument to create a anastomosis according to claim 7 as soon as it is subordinate to any of claims 1 to 5, wherein the tissue retention mechanism further comprises a member of interlock (44a) to retain the drive sleeve and a the clip in the second position and to retain by friction the drive sleeve and clip on top of the member of support of clamping element, such that the bushing of drive and the clip are removed proximally with the support member of fastener after release of the handle. 9. A surgical instrument to create a anastomosis according to any of the claims precedents, in which the instrument further comprises a set drive (20a, 20b) that is coupled to the handle for control the trigger mechanism of fasteners. 10. A surgical instrument to create a anastomosis according to claim 2, or with any of claims 3 to 8 insofar as they are subordinated to the claim 2, wherein the instrument further comprises a drive assembly (20a, 20b) to control the approach of the opposite parts of accommodation. 11. A surgical instrument to create a anastomosis according to claim 2, or with any of claims 3 to 8, as soon as they are subordinated to the claim 2, wherein the instrument further comprises a drive assembly (20a, 20b) that is coupled to the handle to control the trigger mechanism of elements of clamping and to control the approximation of the opposite parts of accommodation. 12. A surgical instrument according to the claim 1, comprising a drive assembly (20a, 20b) fixed at one end to the handle and fixed at the end opposite the drive member, whose drive member is mounted to the clamping element support member such that the drive assembly movement will make a reciprocating movement to the driving member, which, in turn, will make perform a reciprocating movement to the element support member clamping to deform at least a part of the elements of surgical support 13. A surgical instrument according to claim 12, wherein the element support member of subject includes: a firing piston (34a, 34b) that has a proximal end that hooks and engages with the limb impeller after activation of the drive assembly; Y a hammer part (46a) that rests closely on each of the surgical fasteners to deform at least a part of the fasteners surgical after the movement of the drive assembly. 14. A surgical instrument according to the claim 13, wherein the drive member comprises at least a driving hammer (28a1, 28a2) located at the distal end of the same and the firing piston comprises at least one device corresponding capture (38a1, 38a2) of hammer located in the proximal end thereof such that, upon activation of the drive assembly, the driving hammer engages the hammer capture device and lock the drive member to the firing piston, and, after the release of the set of drive, both the driving member and the firing piston They withdraw in the proximal direction. 15. A surgical instrument to create a anastomosis according to claim 6, wherein the tissue retention mechanism retains friction to the bushing drive and to the tissue clip on top of the member of support of clamping element, such that the bushing of drive and tissue clip are removed proximally with the clamping element support member after the drive assembly release. 16. A surgical instrument according to claim 1, wherein the surgical fasteners  are arranged as an ordered set on the member support element.